MA, UNITED STATES, November 13, 2024 /EINPresswire.com/ -- KBA Attorneys, a leading law firm representing victims of medical device injuries, is actively investigating and litigating cases involving Hologic's BioZorb Marker. This action follows the U.S. Food and Drug Administration's (FDA) recent warning about BioZorb devices, urging healthcare providers to return all unused lots due to reports of serious complications. We are licensed in Maryland, North Carolina, Florida and Massachusetts. We are reaching people nationwide for an action in MA.
On Friday, the FDA issued a public health warning regarding BioZorb Marker products, advising healthcare facilities and providers to halt their use and return all unused units. This warning coincides with Hologic Inc.'s HOLX voluntary recall of the BioZorb Marker and BioZorb LP Marker devices, initially designed to help mark surgical sites in soft tissues like breast tissue. However, these devices have been linked to significant health issues, leaving patients at risk.
BioZorb Marker and Its Risks
BioZorb, introduced as a tool to aid in marking soft tissue sites post-surgery, consists of a dissolvable plastic component and a permanent titanium marker. The device was intended to dissolve gradually, leaving the titanium in place for future reference by healthcare providers. Despite its intended purpose, BioZorb has been associated with a series of adverse events, including severe pain, infections, migration, and erosion through the skin. The FDA's recent advisory highlights the risks posed when the device is used beyond its intended purpose.
Why the FDA Warned Against BioZorb
The FDA and Hologic initiated this recall after receiving reports of various complications. Documented issues include pain at the implant site, infection, device migration, and erosion through the skin. Some patients also reported seromas (fluid buildup) and other skin reactions, often severe enough to require medical or surgical intervention.
"BioZorb is not FDA-cleared or approved to fill tissue spaces, improve cosmetic results, or serve as a radiation treatment marker," the FDA stated. Misuse of BioZorb for these unapproved purposes may have contributed to the reported complications, further underscoring the need for caution.
Since its release in 2015, BioZorb has encountered growing scrutiny due to adverse reports. As of October 2024, Hologic received 399 complaints, with 188 directly linked to serious adverse events. The FDA's current advisory aims to mitigate potential harm by urging providers to return any unused BioZorb products and halt further usage.
KBA Attorneys: Fighting for Patients Harmed by BioZorb
KBA Attorneys is dedicated to helping those impacted by the BioZorb Marker. Our firm has a strong track record of advocating for clients affected by defective medical devices, ensuring they receive justice and compensation. For patients who experienced pain, infections, or other health issues from BioZorb, legal recourse may be available to hold Hologic accountable.
"Patients placed their trust in BioZorb as a safe and effective medical device, only to face unexpected harm," said a spokesperson from KBA Attorneys. "We are committed to standing up for these individuals and holding the responsible parties accountable for their suffering."
Steps for Affected Patients and Providers
In response to the recall, both the FDA and Hologic have outlined specific actions for patients and healthcare providers:
For Patients:
• Contact your healthcare provider if you experience any adverse effects related to your BioZorb Marker.
• Removal of the device is not necessary unless recommended by your doctor.
• If you are undergoing radiation treatment, discuss potential risks associated with BioZorb with your provider.
• Report any issues with the device to the FDA via the MedWatch Voluntary Reporting Form.
For Healthcare Providers:
• Cease use of BioZorb Markers and quarantine any unused devices.
• Return unused BioZorb devices to Hologic as per the recall instructions.
• Inform patients with BioZorb Markers of potential risks and provide guidance as necessary.
• Report any observed complications or device malfunctions to the FDA.
These steps aim to prevent additional complications and help manage existing BioZorb-related cases responsibly.
A Legacy of Concern with BioZorb
The FDA's current recall is not the first instance of concern regarding BioZorb. Since its launch, the device has faced scrutiny due to complaints related to pain, device visibility issues, and inflammatory reactions. Previous adjustments by Hologic did little to alleviate ongoing issues, leading to today's heightened FDA oversight and expanded recall.
KBA Attorneys continues to investigate BioZorb cases with a focus on supporting affected patients. The firm's involvement in these cases is part of a broader commitment to protect patients from unsafe medical devices and promote accountability within the healthcare industry.
Contact KBA Attorneys for Legal Support
If you or a loved one has experienced health complications due to the BioZorb Marker, contact KBA Attorneys to explore your legal options. Our team is dedicated to advocating for individuals harmed by medical devices, like BioZorb, ensuring they receive the justice they deserve.
About KBA Attorneys
KBA Attorneys is a trusted law firm focused on representing clients injured by defective medical devices, pharmaceutical drugs, and other corporate misconduct. With a commitment to upholding patients' rights, KBA Attorneys has successfully fought for justice and compensation in numerous high-profile cases. The firm's current investigation into BioZorb Marker injuries exemplifies its dedication to improving healthcare standards and supporting individuals in their time of need.
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BioZorb Marker and Its Risks
BioZorb, introduced as a tool to aid in marking soft tissue sites post-surgery, consists of a dissolvable plastic component and a permanent titanium marker. The device was intended to dissolve gradually, leaving the titanium in place for future reference by healthcare providers. Despite its intended purpose, BioZorb has been associated with a series of adverse events, including severe pain, infections, migration, and erosion through the skin. The FDA's recent advisory highlights the risks posed when the device is used beyond its intended purpose.
Why the FDA Warned Against BioZorb
The FDA and Hologic initiated this recall after receiving reports of various complications. Documented issues include pain at the implant site, infection, device migration, and erosion through the skin. Some patients also reported seromas (fluid buildup) and other skin reactions, often severe enough to require medical or surgical intervention.
"BioZorb is not FDA-cleared or approved to fill tissue spaces, improve cosmetic results, or serve as a radiation treatment marker," the FDA stated. Misuse of BioZorb for these unapproved purposes may have contributed to the reported complications, further underscoring the need for caution.
Since its release in 2015, BioZorb has encountered growing scrutiny due to adverse reports. As of October 2024, Hologic received 399 complaints, with 188 directly linked to serious adverse events. The FDA's current advisory aims to mitigate potential harm by urging providers to return any unused BioZorb products and halt further usage.
KBA Attorneys: Fighting for Patients Harmed by BioZorb
KBA Attorneys is dedicated to helping those impacted by the BioZorb Marker. Our firm has a strong track record of advocating for clients affected by defective medical devices, ensuring they receive justice and compensation. For patients who experienced pain, infections, or other health issues from BioZorb, legal recourse may be available to hold Hologic accountable.
"Patients placed their trust in BioZorb as a safe and effective medical device, only to face unexpected harm," said a spokesperson from KBA Attorneys. "We are committed to standing up for these individuals and holding the responsible parties accountable for their suffering."
Steps for Affected Patients and Providers
In response to the recall, both the FDA and Hologic have outlined specific actions for patients and healthcare providers:
For Patients:
• Contact your healthcare provider if you experience any adverse effects related to your BioZorb Marker.
• Removal of the device is not necessary unless recommended by your doctor.
• If you are undergoing radiation treatment, discuss potential risks associated with BioZorb with your provider.
• Report any issues with the device to the FDA via the MedWatch Voluntary Reporting Form.
For Healthcare Providers:
• Cease use of BioZorb Markers and quarantine any unused devices.
• Return unused BioZorb devices to Hologic as per the recall instructions.
• Inform patients with BioZorb Markers of potential risks and provide guidance as necessary.
• Report any observed complications or device malfunctions to the FDA.
These steps aim to prevent additional complications and help manage existing BioZorb-related cases responsibly.
A Legacy of Concern with BioZorb
The FDA's current recall is not the first instance of concern regarding BioZorb. Since its launch, the device has faced scrutiny due to complaints related to pain, device visibility issues, and inflammatory reactions. Previous adjustments by Hologic did little to alleviate ongoing issues, leading to today's heightened FDA oversight and expanded recall.
KBA Attorneys continues to investigate BioZorb cases with a focus on supporting affected patients. The firm's involvement in these cases is part of a broader commitment to protect patients from unsafe medical devices and promote accountability within the healthcare industry.
Contact KBA Attorneys for Legal Support
If you or a loved one has experienced health complications due to the BioZorb Marker, contact KBA Attorneys to explore your legal options. Our team is dedicated to advocating for individuals harmed by medical devices, like BioZorb, ensuring they receive the justice they deserve.
About KBA Attorneys
KBA Attorneys is a trusted law firm focused on representing clients injured by defective medical devices, pharmaceutical drugs, and other corporate misconduct. With a commitment to upholding patients' rights, KBA Attorneys has successfully fought for justice and compensation in numerous high-profile cases. The firm's current investigation into BioZorb Marker injuries exemplifies its dedication to improving healthcare standards and supporting individuals in their time of need.
Robert Price
KBA Attorneys
+1 855-267-3127
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